Icecure Medical Ltd (ICCM) 2025 Q1 法說會逐字稿

Good morning, and thank you for standing by. (Operator Instructions) Please be advised that today's conference is being recorded.

I would now like to turn the conference over to Michael Polyviou. Please go ahead.

Thank you, Joni, and welcome to IceCure Medical's conference call to review the financial results as of and for the three months ended March 31, 2025, and provide an update on recent operational highlights. You may refer to the earnings press release that we issued earlier this morning.

Participating on today's call are IceCure Medical's CEO, Eyal Shamir; and the company's CFO and COO, Ronen Tsimerman.

Before we begin, I will now take a moment to read a statement about forward-looking statements. This call and the question-and-answer session that follows it contain forward-looking statements within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Words such as expects, anticipates, intends, plans, believes, seeks, estimates and similar expressions or variations of such words are intended to identify forward-looking statements.

For example, we are using forward-looking statements in this presentation when we discuss our prospective post-market study plan and our beliefs and expectations following our meeting with the FDA at the end of April. The expectation of the FDA's final marketing authorization decision for ProSense upon approval of the post-market study plan, our plan to commence commercial sales in parallel with running our post-market study, our belief that additional reimbursements may become available based on regulatory approval and our potential catalysts for the rest of 2025.

Because such statements deal with future events and are based on IceCure's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of IceCure could differ materially from those described in or implied by the statements during this call.

The forward-looking statements contained or implied during this call are subject to other risks and uncertainties, many of which are beyond the control of the company, including those set forth in the Risk Factors section of the company's annual report on Form 20-F for the year ended December 31, 2024, filed with the SEC on March 27, 2025, which is available on the SEC's website at www.sec.gov.

The company disclaims any intention or obligation, except as required by law, to update or revise any forward-looking statements, whether because of new information, future events or otherwise. This conference call contains time-sensitive information and speaks only as of the live broadcast today, May 28, 2025.

I will now turn the call over to IceCure Medical's CEO, Eyal Shamir. Eyal, please go ahead.

Thanks, Michael, and hello, everyone, and thank you for joining us today to review our first quarter 2025 results as we continue to experience momentum and continuous growth in ProSense System and disposable probe sales in North America. Ronen will provide further detail on the company financial performance in the first quarter, and I will focus my comments on more recent development, namely the positive high-level meeting we had with the FDA at the end of April.

We met with the leadership of the FDA and its Center of Device and Radiology Health CDRH to discuss our marketing authorization request for ProSense in the treatment of early-stage low-risk breast cancer when combined with adjuvant endocrine therapy for women aged 70 and over, a demographic comprising of approximately 46,000 patients annually in the US.

During the meeting, the FDA requested that we will conduct a post-market study after marketing authorization has been granted, which we believe represents a positive signal. The FDA requested that we will prepare this post-market study plan and delivery to the Center of Device and Radiology Health CDRH for review and comments. The FDA's decision on marketing authorization is expected upon the post-market study plan approval.

I am pleased to report that after the team's diligent work to prepare the plan, we recently submitted it to the Center of Device and Radiology Health for its review. As you all well known, we have been anticipating the FDA decision on cryoablation for early-stage breast cancer since the beginning of the year. It is our hope that the review of our post-market study plan will be the final step leading up to an FDA decision about which we are optimistic.

Upon the FDA granting ProSense cryoablation marketing authorization in early-stage breast cancer for women aged 70 and older, we will commence the commercial phase for this indication while simultaneously running the post-market study, which would afford the company access to reimbursement under the CPT 3 code, which covers $3,800 for the treatment facility cost. We believe that additional reimbursement may become available based on regulatory approval and any recommendation from professional medical associations.

Our US commercial team is ready and eager to serve doctors and patients to deliver ProSense, which will become the first-in-class minimally invasive option for women. We see this as a major advancement in women health and the new part in breast cancer care.

The news of the FDA request for our post-market plan was well timed and very well received at the American Society of Breast Surgeons 2025 Annual Meeting, which took place in early May. We were encouraged by high level of interest in ProSense as a large number of breast surgeons approach our booth, asking how they could participate in our planned post-market study and how they could offer ProSense to their patients following marketing authorization.

Moreover, ASBrS leadership as giving breast cryoablation as a good deal of attention over the past years, including this year. So we believe that this and the positive recommendation of the FDA Advisory Committee meeting in November 2024 give us an awareness advantage should the FDA marketing authorization be granted.

Cryoablation for breast cancer was included in a permanent presentations, including the American Society of Breast Surgeons presidential address and its best paper for 2024 review as our ICE3 study was named one of the best paper of the year.

In addition to the ASBrS, we are receiving a new interest in ProSense from interventional radiologists and other doctors following the FDA request for a post-market plan. As we wait the FDA decision, we also look ahead to other potential catalysts for the rest of 2025, including regulatory filing and potential approvals in Japan and in Israel. Meanwhile, the number of published independent study of ProSense continue to increase globally.

Before I turn the call over to Ronen to review our Q1 results, I want to comment on the continued support and friendly relationship we enjoy with our largest shareholder, Mr. Li Haixiang of Epoch Partner Investor Limited. Epoch and Mr. Li, also a Board member of the company, once again demonstrated confidence in our company, our technology and our ability to execute our business plan by providing a $2 million unsecured loan through Epoch and at an interest rate that matches the US treasure bills.

This bridge loan will be prepaid prior to its one year term upon Epoch participation in an equity transaction. This loan affords us additional flexibility as we wait the FDA decision.

I will now turn the call over to Ronen.

Thank you, Eyal. For the three months ended March 31, 2025, revenue representing ProSense System and disposable probe sales was $725,000 compared to $743,000 for the three months ended March 31, 2024. Revenue was driven primarily by the increase in sales in North America and Europe, offset by a decline in sales in Asia.

Gross profit for the three months ended March 31, 2025, was $218,000 compared to $269,000 for the three months ended March 31, 2024. Gross margin was 30% for the three months ended March 31, 2025, compared to 36% in the three months ended March 31, 2024. Due to the low revenue base, we continue to expect revenue and gross profit to fluctuate quarter-to-quarter as we focus on building out our commercial infrastructure and scale sales. We do not expect a material change in revenues before receiving FDA marketing authorization decision.

Total operating expenses for the three months ended March 31, 2025, were $3.88 million compared to $3.92 million for the three months ended March 31, 2024. Net loss was $3.59 million or $0.06 per share for the three months ended March 31, 2025, compared to a net loss of $3.61 million or $0.08 per share for the same period last year.

As of March 31, 2025, the company had cash equivalents, including short-term deposits of approximately $6.0 million. As of May 27, 2025, we had cash and cash equivalents of approximately $6.2 million, which includes the $2 million unsecured bridge loan from Epoch. Between January 13, 2025, and May 27, 2025, the company raised $2.65 million in net proceeds from the sales of 2,124,429 ordinary shares under its at-the-market offering facility.

Operator, we will now open the call for Q&A.

(Operator Instructions) Anthony Vendetti, Maxim Group.

So I'm glad to hear that you have submitted the proposed post-market study to the FDA. That's a significant milestone. Just as you mentioned that the CDRH, the Center for Devices and Radiological Health at the FDA is the division within the FDA that is going to review and ultimately decide on the approval of the post-market study. First, is it still expected to be a minimum of 400 patients over 25 sites? And is there any indication from the FDA of when they would potentially respond to the submission of your post-market study?

Anthony, this is Eyal. Yes, it still will be the post-market study, which is in the last few years is pretty common for de novo approvals will require 400 patients in at least 25 sites. The top management of CDRH and including the Director Officer can promise us that top management will continue to review it, and they will be a part of the process on the top of the review team, but they cannot guarantee us a specific time. We submitted quite a big package, and I'm sure that they will review it, and we will have a continuous discussions like we did until now.

Okay. I'm just curious, how -- I know these packages are fairly large and voluminous in terms of length. Do you -- approximately how many pages was the package that you submitted?

Quite a lot. That's a lot of information.

Okay. And then assuming the study is reviewed and approved, how long is that study -- the post-market study expected to take?

This is not yet finalized with the FDA, but I believe from what we saw in other PMS that the FDA would like to see that the recruitment time will be within three years.

Recruitment within three years, okay.

So the 400 patients should be recruited during the three years.

Okay. And you did mention in your prepared remarks that there's an opportunity potentially for expanded reimbursement. Can you get any more specific on what that potential is?

Certainly, as soon as we will have more records, more claims on our specific code, CPT 3 code for breast cancer and additional information on the actual cost that the site will put as part of the claims, we will be able to increase, we believe, and according to what we heard from our consultants, reimbursement consultant that we will be able to increase the CPT 3 code. This is number one.

Number two, after the FDA will grant us the marketing authorization, we will be able to apply to AMA to move from CPT 3 to CPT 1, which includes also the physician fee. In parallel, we are doing all the preparation for that meta-analysis and some other requirements that need to be as part of the AMA. So we will apply to the AMA. It will be a process, but we will seek also CPT 1 code.

Okay. Great. And then just lastly before I jump back in the queue. Terumo, your partner in Japan, is still on schedule to file for approval in the second half of '25. What is the size of the population there?

I know in the press release, 46,000 women are potential candidates for the ProSense System. What about Japan? What's the size of the market or the opportunity there?

The total number of patients that has breast cancer are a bit more than 100,000, between 100,000 and 105,000 new cases every year. Very similar to the US, almost 2/3 of them are low-risk early-stage breast cancer.

The assumption that Terumo present at the moment that it will not be with the limitation of age and even tumour size, maybe very similar to what we have by CE and many other regulatory approvals with just breast cancer, which not include any limitation or even like an independent study that runs now in Europe by one of the top three centers in Europe for oncology that they are doing patients who are 50 and up in both Luminal A and Luminal B. So it will not be that limited like we are going to have in the US at the beginning.

Kemp Dolliver, Brookline Capital Markets.

Great. Can you give any more details on the geographic breakdown of revenue this quarter? How much growth you saw in US and North America and size of the decline in Asia?

Thank you for the question, Kemp. So in North America, we've seen an increase of about 11% year-over-year. And in Europe, we've seen an increase of about 60% from -- again, year-over-year. So we're very happy about it. In Japan, the numbers were not very big. So the decrease was about 60%. And again, the numbers fluctuate between quarters and also in other parts in Asia, about 40%. But again, the numbers are fluctuating and they weren't very big anyway.

Great. And these were entirely probe and system sales this quarter?

Yes, probes and system sales, there was no revenue recognition this quarter.

Yi Chen, HC Wainwright.

This is Eduardo on for Yi. Curious if there's -- the ProSense is subject to any of the new tariffs for US markets, kind of get some clarity on that.

So yes, I will take the question. Thank you for the question. Yes, currently, we know that there is some kind of a freeze of the taxes. But again, we will need to see when President Trump decides exactly what to do. But at the initial, yes, we were affected or influenced by the tariffs that were stated by the US administration.

Understood. And I'm kind of curious if for the post-market approval, once the study -- assuming the study goes through, do you guys plan to expand your sales team in addition to the one you currently have?

This is Eyal. Yes, of course, after we will have the marketing authorization grant, we plan to increase the sales team. We have a very professional Vice President for North America, Mr. Shad Good, who is bringing over 20 years of experience in the breast field from J&J, Mammotome and others. So we will build the team, sales rep, regional sales manager, clinical application as we plan that quite important part of our future growth will come from the US market.

Understood. And kind of also curious what strategies you guys have for pricing and sales, specifically, you guys primarily focused on purchasing outright, you guys have leases or pay-per-use agreements in place, kind of getting more clarity on your commercial strategies in that regard.

I believe that it will be kind of 60-40 between a placement and selling the consoles, like it's pretty common in this type of capital equipment or maybe half-half. But for placement, we will require a very important commitment of a monthly number of probes over two to three years for a higher price. And we will have also a separated business model that we will sell the console and of course, the single-use probe.

This concludes the question-and-answer session. I will turn the call over to Eyal Shamir for his concluding statements. Please go ahead.

Thanks for participating on today's call. We look forward to the FDA decision on marketing authorization of ProSense in early-stage breast cancer. We also believe that the post-market study should we receive the FDA marketing authorization will drive further interest in ProSense and has the potential to accelerate adoption. Our US sales team is ready, and they are fielding questions from prospective study sites at this time. We hope to revert back with our shareholders soon with further news. Have a great day, everyone.

Thank you. This concludes the IceCure first quarter 2025 results conference call. Thank you for your participation. You may go ahead and disconnect.